Nursing Care With Patients With Venous Leg Ulcers

Venous Leg Ulcers Clinical Trial

Official title:

Nursing Care With Patients With Venous Leg Ulcers - Developing an Internet-based Education Program and Evaluation of Its Effectiveness

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02224300
• Other study ID #: LAPHOI
• Status: Unknown status
• Phase: Phase 2
• First received: August 9, 2014
• Last updated: August 22, 2014
• Start date: August 2014
• Est. completion date: December 2014

Study information

• Verified date: August 2014
• Source: University of Turku
• Contact: Minna S Ylönen, PhD-candidate
• Phone: +358400667809
• Email: misuyl[@]utu.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aims are:

• develop an Internet-based education programme about venous leg ulcer nursing care (ELC)

• evaluate the clinical, cognitive and economical outcomes of education programme

Research questions are:

1. What are the cognitive outcomes of ELC (perceived knowledge, attitudes towards venous leg ulcer nursing care, theoretical knowledge level and practical knowledge)?

Hypotheses for research question 1 are:

1. Nurses using the ELC will have better knowledge (perceived, practical and theoretical knowledge) than those who will not use the ELC.

2. Nurses using the ELC will have more positive attitudes towards venous leg ulcer nursing care than those who will not use the ELC.

2. What are the clinical outcomes of ELC (ulcer healing, ulcer size, treatment supplies)?

Hypotheses for research question 2 are:

1. Ulcer healing progresses better among patients who are taken care by nurses using the ELC.

2. Ulcer sizes will be 10 % smaller among the patients cared for nurses using the ELC.

3. Nurses using the ELC will use mire adequate treatment supplies than those who will not use the ELC.

3. What are the economical outcomes (treatment time and supply usage) of ELC?

Hypothesis for research question 3 is:

1. The economical expenditures will be lower among nurses using the ELC.

The ultimate aim is to promote evidence-based nursing care among patients with venous leg ulcer.

Description:

The study takes place in home-care in two Finnish municipality, which are similar size and staff structure and working ideology are basically the same.

Enrolment of participants has started with information occasion in both municipalities in June 2014. Nurses were asked to fill the Patients Clinical Situation Questionnaire, handouts and forms for informed consent were delivered. (Figure 1) All eligible nurses and patients will be identified with Patient Clinical Assessment. The sample size was determined with power analysis and the result was that 200 nurses are needed in the intervention group and 100 nurses in the comparison group.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 300
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion criteria for nurses:

1. Working in municipality home-care

2. Permanent attachment or three months or longer temporary post in municipality home-care

3. Working in home-care area where patients with chronic leg ulcer are taken care during the study

Exclusion criteria for nurses:

1. Working in other place than home-care There are no other exclusion criteria.

Inclusion criteria for patients to observation are:

1. Home health-care patient aged 60 or over

2. Venous leg ulcer diagnosis

3. Chronic ulcer in the lower leg without diagnosis

Exclusion criteria for patients:

1. An ulcer with other diagnosis than venous leg ulcer diagnosis There are no other exclusion criteria for patients.

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcers

Intervention

Behavioral:
• Internet-based education of venous leg ulcer nursing care
Intervention is delivering the ELC (Electronic Learning of venous leg ulcer nursing care) to home health-care nurses (registered nurses, public health nurses and licensed practical nurses) . The ELC development was based on the integrative literature review about nurses' knowledge gaps on venous leg ulcer nursing care. The pedagogical basis of the ELC is constructivism and blended learning approach. The ELC comprises contact learning and distance learning. Content of ELC is evidence-based information already existing in Internet and the basis of the information is the Finnish Current Care Guidelines for Chronic leg ulcers (2014), which are evidence-based clinical practice guidelines. They are intended as basis for ulcer treatment decisions, and guidelines can be used by nurses and other healthcare professionals.

Locations

Country	Name	City	State
Finland	Homecare	Turku

Sponsors (1)

Lead Sponsor	Collaborator
University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in nurses´ knowledge before and after the education	Knowledge is divided into nurses´ perceived knowledge, practical and theoretical knowledge.; Changes in perceived knowledge will be measured with structured self-completed questionnaire.; Changes in practical knowledge will be measured with structured observation. Changes in theoretical knowledge will be measured with structured questionnaire (knowledge-test).	Baseline, Week 8 and Week 12
Secondary	Changes in nurses´ attitudes towards patients with venous leg ulcers before and after the education	Changes in attitudes will be measured with structured questionnaire.	Baseline, Week 8 and Week 12
Secondary	Changes in clinical variables; venous leg ulcer size.	Changes in venous leg sizes variables will be measured during observations. Each venous leg ulcer will measured with paper ruler.	Baseline, Week 8 and Week 12
Secondary	Changes in clinical variables; adequacy of the supplies used.	Changes in adequacy of supplies used will be measured with structured observation.	Baseline, Week 8 and Week 12
Secondary	Changes in economical variables cost of supplies and treatment time.	Changes in economical variables will be measured with structured observation.	Baseline, Week 8 and Week 12